MEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS
FDA premarket approval P860004/S202 · decided 2014-02-25
Approval details
- PMA number
- P860004
- Supplement
- S202
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2014-01-28
- Decision date
- 2014-02-25
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR DEVICE REFILL KIT MODEL 8551TO REORDER THE WARNINGS AND PRECAUTIONS ACCORDING TO MEDICAL IMPORTANCE, TO REMOVE INFORMATION FOUND IN THE PREVIOUSLY APPROVED INSTRUCTIONS FOR USE THAT IS NOT APPLICABLE TO MODEL 8551, AND TO ALIGN VERBIAGE WITH THE UPDATED MODEL 856X REFILL KIT INSTRUCTIONS FOR USE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |